NCT07426484

Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy

A Phase IV Master Protocol of Cosibelimab in Special Populations With Advanced Cutaneous Squamous Cell Carcinoma (CosiMaster)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is study is to evaluate the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC). The name of the drug involved in this research study is: -cosibelimab (a type of an anti-PD-L1 antibody)

Detailed description

This is a Phase IV, multi-site, multi-cohort, open-label clinical trial investigating the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC). Checkpoint Therapeutics is supporting this research study by providing the study drug, cosibelimab. Participants will be enrolled into one of two study groups: Group A or Group B. Cosibelimab is FDA-approved for the treatment of advanced cutaneous squamous cell carcinoma The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized Tomography (CT) scans, or Positron Emission (PET) scans, electrocardiograms (ECGs), Tumor biopsies and aspirations. It is expected that about 80 people will take part in this research study.

Conditions

• Cutaneous Squamous Cell Carcinoma
• Skin Cancer

Interventions

Type	Name	Description
DRUG	Cosibelimab	Anti-PD-L1 antibody, single dose vials, via intravenous (into the vein) infusion per protocol
DRUG	Prednisone	Corticosteroid, per standard of care
DRUG	Sirolimus	mTOR Inhibitor, per standard of care
DRUG	Everolimus	mTOR Inhibitor, per standard of care

Timeline

• Start date: 2026-07-01
• Primary completion: 2030-12-15
• Completion: 2032-12-15
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study